Healthy Japanese
Conditions
Sponsors
OSAKA SODA CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose BMI is 23 kg/m2 or more and less than 30 kg/m2 at screening 6. Individuals whose visceral fat area is large at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who are on a diet 8. Individuals who have an exercise habit 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 11. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of visceral fat area at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change and percentage change in visceral fat area from screening at 12w 2. The measured values of total fat area, subcutaneous fat area, body weight, body mass index (BMI), body fat percentage, fat mass, lean mass, muscle mass (whole body, right leg, left leg, right arm, left arm, trunk), waist circumference, AST (GOT), ALT (GTP), gamma-GT (gamma-GTP), total cholesterol (T-Cho), HDL-cholesterol (HDL-Cho), LDL-cholesterol (LDL-Cho), triglycerides (TG), glucose (GLU), hemoglobin A1c, lactic acid, pyruvic acid, and other metabolic markers at 12w, and their changes and percentage changes from screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed